Agilent Announces Full Workflow for US EPA Method 1633 for Targeted PFAS Analysis

Agilent Technologies Inc. (NYSE: A) announced today a highly-anticipated, complete workflow solution for targeted per- and polyfluoroalkyl substances (PFAS...

June 07, 2023 | Wednesday | News
Janssen Seeks FDA Approval for CARVYKTI® in Early Treatment of Multiple Myeloma

Application is supported by data from the Phase 3 CARTITUDE-4 study, which showed significant improvement in primary endpoint of progre...

June 07, 2023 | Wednesday | News
Ascentage Pharma's Olverembatinib Recommended for Second Breakthrough Therapy Designation in China for SDH-Deficient GIST

This marks the second BTD granted to olverembatinib by the CDE, with the first one granted in March 2021 for the treatment of patients with chronic-phase c...

May 31, 2023 | Wednesday | News
GE HealthCare's New Deep Learning Solution Cleared by FDA for Enhanced PET/CT Image Quality, Reinforcing AI Leadership

A type of artificial intelligence (AI), Deep Learning (DL) technology can advance medical imaging capabilities by providing more robust, accurate, and da...

May 31, 2023 | Wednesday | News
New CapnoPen® CP-001k receives CE certification (MDR)

Stéphane Rohan Laurent, Capnopharm’s VP Sales & Business Development, comments: “Receiving CE certification constitutes a landm...

May 31, 2023 | Wednesday | News
SK bioscience Receives Marketing Authorization for its COVID-19 Vaccine from UK MHRA

 SKYCovion is the world’s first-ever vaccine developed using the RoseTTAFold, a software tool that uses deep learning. SK bioscience has appl...

May 30, 2023 | Tuesday | News
Lexicon's INPEFA™ (sotagliflozin) FDA Approved for Heart Failure Treatment

INPEFA reduced the risk of total occurrence of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits by 33% compared to ...

May 29, 2023 | Monday | News
Iovance Biotherapeutics' Lifileucel for Advanced Melanoma Receives FDA Acceptance

First Potential Approval of an Individualized, One-Time Cell Therapy  for Patients with Advanced Melanoma Iovance Biotherapeutics, Inc. (NASDAQ: IOVA...

May 29, 2023 | Monday | Regulatory
Catalent Strengthens Cryogenic Capabilities in Shiga, Japan, Facility for Cell and Gene Therapy

State-of-the-art cryogenic freezers alongside material transfer equipment have been installed that are designed to retain the integrity of investigational ...

May 25, 2023 | Thursday | News
FDA Approves New Treatment for Pneumonia Caused by Certain Difficult-to-Treat Bacteria

According to the World Health Organization, Acinetobacter species top the list of critical bacterial pathogens that pose the greatest threat to human ...

May 24, 2023 | Wednesday | News
Rakuten Medical Initiates Global Phase 3 Trial of Alluminox™ Treatment for Head and Neck Cancer in India

The Company has been granted permission from the Indian Central Drugs Standard Control Organization (CDSCO) to conduct its global, pivotal Phase 3 clinical...

May 23, 2023 | Tuesday | News
Thermo Fisher Scientific's Immunoassays Receive FDA Clearance for Preeclampsia Risk Assessment

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced that the U.S. Food and Drug Administration (FDA) has cleare...

May 20, 2023 | Saturday | News
10x Genomics Wins Permanent Injunction Against NanoString's CosMx Products

10x Genomics, Inc. (Nasdaq: TXG), a leader in single cell and spatial biology, today announced that it has won an injunction in its patent litigation ...

May 18, 2023 | Thursday | News
FDA Approves Novel Drug to Treat Moderate to Severe Hot Flashes Caused by Menopause

"Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life," said Janet Maynard, M.D., M.H.S., direct...

May 15, 2023 | Monday | News

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